EP SALES TRAINING Chilli II™ Cooled Ablation Catheter.

EP SALES TRAININGChilli II™ Cooled Ablation Catheter

BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation CatheterAgenda

Chilli II™ - Features Atrial Fibrillation Positioning Internal vs. External Brochure Competition Cabling Chart Evaluation Model How to Use Generators Troubleshooting Guide Clinical Evidence Conclusion


Chilli II™ Cooled Ablation CatheterFeatures

Handle• Tension Control•Bi-wing Steering•Handle Ergonomics

Proximal Shaft•Torqueability•Pushability •Trackability

Tip Electrode•Tip Size•Cooling•Temperature Sensor

Distal Segment• Length & Curve Shape• Performance• Active Steering


Chilli II™ Cooled Ablation CatheterFeature Summary

Blazer II™Blazer II™

HTDBlazer II XP™

Blazer II XP™ HTD

Chilli II™

Standard Medium

Extended

Standard Torque ------ ------ ------High Torque ------

Small ------ ------ ------ ------Standard

Large Asymmetric

Passive Active ------ ------ ------ ------

7f/4mm ------ ------ 8f/8mm Str ------ ------ ------8f/8mm VM ------ ------ ------ ------

Exposed Imbedded ------ ------ ------ ------

Thermistor Thermocouple ------ ------ ------ ------

Cooling

Tip Electrode

Temperature Sensor

CATHETER FAMILY CONFIGURATIONSDISTAL SHAFT

CHARACTERISTICS

Tubing Lengths

Tubing Firmness

Curve Shapes


CircuCool ™ Pump Features

SettingsFlow Rate: Constant: 0.6 ml/sec or 36ml/min

Pressure Limit: Less than 300 psi

Dimensions and Weight Height: 9.0” (22.9 cm) Width: 11.0” (27.9 cm) Depth: 11.80” (30.0 cm) Weight: 9.6 pounds (4.4 kg)

Special Note: Pump comes with US power plug. Need to order appropriate EU country plug


Chilli II™ Cooled Ablation Catheter Atrial Fibrillation

Anatomy & Conduction• Left Atrium

– Four PVs enter the left atrium (left, right, superior and inferior)

– A fib thought to originate in the PVs – Thought to be a triggered tachycardia

Three Types• Paroxysmal

– starts and stops spontaneously– Variable durations

• Persistent– starts spontaneously– stops only with electrical or medical

cardioversion• Permanent

– present all the time– restoring sinus rhythm is not possible



Mapping Atrial Fibrillation• Dx placed in CS and in PVs

– CS = to pace the left atrium• Decapolar

– PVs = to check for electrical activity and isolation• Laso, Mesh, Constellation

catheters

• Rx in left atrium• Done with a transeptal

puncture across the septum



Ablating Atrial Fibrillation• Various techniques but

essentially try to isolate the PVs by encircling and possibly making other connecting linear lesions



Summary• Symptoms

– Palpitations– Dizziness– Short of Breath

• Rhythm– Narrow QRS– Irregular– Paroxysmal, Persistant and Permanent

• Ablation– Encirclement of the Pulmonary Veins– Possible other left atrial connecting lesions


Chilli II™ Cooled Ablation CatheterPositioning DISEASE CATHETER

AVNRT Blazer IIFLUTTER Blazer XP

AFIB CHILLI II

Atrial FibrillationCLINICAL REQUIREMENTS CATHETER FEATURES

Deep lesions for the Roof, Foot, and MV of the LA where the Atrial Tissue is thick

Cooled 7f,4mm tip electrode

Reduce risks of secondary complications of coagulum/thrombus formation that may result in TIAs or strokes.

Cooled 7f,4mm tip electrode

Micromovement to create linear lesion Bi-Wing Steering Knob and Mechanical Steering Mechanism

Reduce risk of secondary complications of fluid overload such as venal hypertension, renal hyperactivity and pulmonary insufficiency.

Closed Loop, reciruculating cooling fluid

Stable tip contact throughout linear lesion HTD Distal + Proximal tubing

Access and moving around the entire LA Proximal tubing + Bi-directional Steering


“Irrigated RF ablation: power titration and fluid management for optimal safety and efficacy”, Stevenson et al.

Chilli II™ Cooled Ablation CatheterInternal vs. External

Not a major safety concern in most patients…. BUT:

Consider that 1l of normal saline contains 9grams of sodium chloride, which includes 3.6grams of sodium – patients with heart failure (CHF) or hypertension are typically advised to reduce the sodium in their diet to 2.4 grams daily. In addition to the volume load, each liter of saline irrigation contains 1,000 units of heparin. Thus, there is the potential for greater anticoagulation that would be achieved without open- irrigation.Factors that predispose to pulmonary edema:

• Heart Failure (CHF)• Heart disease (AV disease, MV disease, EF<35%, miocardial infarction)• Renal insufficiency• Diabetes mellitus• Advanced age• Multi-system disease (i.e. Autoimmune disease) or aggressive therapy (chemiotherapy or radiotherapy)

BSC Confidential. For Internal Use Only. Do not Copy or Distribute“Irrigated RF ablation: power titration and fluid management for optimal safety and efficacy”, Stevenson et al.

Chilli II™ Cooled Ablation CatheterInternal vs. External

Consequences of Saline Administration during Irrigation:• Increase of venous pressure• increase in renal excretion• pulmonary edema:

• increase respiratory rate• agitation• dyspnea• tachycardia• decrease of peripheral oxigen saturation • extremities edema

For this reasons eventual later treatment become necessary:• administration of oxygen• administration of intravenous diuretic drugs• administration of inotropic agents (i.e. dopamine)• endotracheal intubation and assisted ventilation


Chilli II™ Cooled Ablation Catheter Brochure

ClinicalBenefits

OrderingInfo

POSITIONINGPOSITIONING

TechnicalInfo



ClinicalBenefits

OrderingInfo

POSITIONINGPOSITIONING

TechnicalInfo


Set Up GuideTroubleshooting GuideOrdering Info



Chilli II™ Cooled Ablation Catheter Competition

COMPETITOR PRODUCT Medtronic Sprinkler™ St J ude Medical / IBI Therapy™ CoolPath Biosense Webster J ohnson & J ohnson

Thermocool™


Chilli II™ Cooled Ablation Catheter Competition

Competitor ProductPUMP FLOW Steering Handle Cooling Manual/Auto Con/Var Uni/Bid Piston/B-w Int/Ext

Medtronic Sprinkler™ Manual Var Uni Piston Ext

St J ude/ IBI Therapy™ CoolPath Manual Var Uni Piston Ext

J &J Thermocool™ Auto with integrated Stockert Var Uni Piston Ext

BSC Chilli I I™ Auto Const Bid B-w Int

FEATURES

Con/Var --- Constant/Variable Uni/Bid --- Unidirectional/Bidirectional Piston/B-w --- Piston/B-Wing Int/Ext --- Internal/External


Chilli II™ Cooled Ablation Catheter Cabling Chart

Catheter can be connected to: ▪ EPT 1000XP™ generator (BSC)

Serial Number above▪ Maestro 3000™ generator (BSC)▪ Stockert generator▪ Osypka generator

Chilli II™ cannot be used with Medtronic and IBI generators.


Connection with Navx System (St Jude Medical)

Chilli II™ Cooled Ablation Catheter Cabling Chart

1 M0046 2062 0

1 M004 2071 01 ESI cable (42-04322) 1 ESI cable (42-04323)

1ESI filter box # 75-04452-001 before pod

Connect BSC to NAVx

Product Units Catheter Units Cable


Chilli II™ Cooled Ablation Catheter Evaluation Model

When preparing the evaluation of new customer please follow the SIX easy steps outlined below:

STEP 1:

Schedule minimum two cases either the same or successive days:• Blazer - NO EXPERIENCE schedule one FLUTTER and one AFIB

case;• Blazer - EXPERIENCED schedule two AFIB cases.

STEP 2:

The evaluation is to be performed with a BSC RF Generator Maestro 3000™.


STEP 3 (FOR FLUTTER ONLY):

Suggest to Physician to use the Blazer II XP™Large Curve with a high torque tubing, for added performance. If Physician is accustomed to using a sheath, comment HTD should eliminate this need but order a 5890ST just in case.


Reach Reach and and

Large HeartsLarge Hearts


STEP 4 (FOR AFIB ONLY): :

Suggest to the physician to use Chilli II™ Standard Curve and order a Large Curve as a backup for physicians with sheath manipulation and trackability issues.


All- PurposeAll- PurposeAnd And

Most RobustMost Robust

Large HeartsLarge HeartsAnd And

Distal Flexibility Distal Flexibility


STEP 5:

Utilize the following

chart of part numbers to identify ALL of the

components that you

should order for

the evaluation.


Product Units Catheter Units CableCHILLI II 2 M004 EPT9031K2 0 2 M004 681 0

2 M004 EPT9031 0 2 M004 681 0

CircuCool 1 M004 8500 0 1 M004 3536010 204 M00435 2104 0

MAESTRO 1 M004 21000TC 0 2 M004 3536010 201 M004 21870T 0 5 M004 354 0

2 M004 653S 02 M004 613 0

1 M0046 2062 0



Connect BSC to NAVx

AFIB EVALUATION CATHETER CHECKLIST


STEP 6: Before doing the ablation make the test on Maestro 3000™ - as described in the following slide.The test must be done in order to verify the compatibility of the generator with the recording system installed in the cat lab.

Tester required.



Connection with Navx System (St Jude Medical)


1 M0046 2062 0



Connect BSC to NAVx

Product Units Catheter Units Cable


Chilli II™ Cooled Ablation Catheter How to Use

POWER TEMP TIMEAFIB 35W 47ºC 30sec

FLUTTER 45W 47ºC 30sec

Generator Maximum ValuesArrhythmia

Hi FlowLo Flow/

Coag Coronary

Sinus15W ----- 41ºC 30 sec

Scar Tissue 30W 25W 47ºC 30sec

Thick Tissue 30W 25W 47ºC 30sec

Cardiac Tissue

Generator Initial SettingsPOWER

TEMP TIME


ECG keysAFIB: PV isolation (no double potential where previously seen)Ablation ProblemHigh impedance: • Char or coagulum on the catheter tip: wipe catheter• Poor contact: need better reposition for better tip contact

Noisy Signals during ablation• Verify amplification, clipping and filtering parameters of recording

machine are properly set.• Verify cable connections are not loose or faulty• Verify generator on separate electric circuit from recording machine• Disconnect and turn off non-essential equipment.• Verify tip electrode is clean.• Consider changing AMP or POD

Chilli II™ Cooled Ablation Catheter How to Use


11 error codes exist. Here listed meaning & solution.Brochure available.

Chilli II™ Cooled Ablation Catheter Maestro 3000™ Troubleshooting


“Clinical study of the efficacy of a cooled-tip catheter ablation system for common atrial flutter.”Okishige K et Al.Cardiovascular Center, Yokohama Red Cross Hospital, Japan. [email protected] J. 2004 Jan;68(1):73-6.

Chilli II™ Cooled Ablation Catheter Clinical Evidence

PRODUCT Chilli™ SUCCESS RATES 100% NUMBER of PATIENTS 33


“Prospective randomized comparison of cooled radiofrequency versus standard radiofrequency energy for ablation of typical atrial flutter.”Atiga WL, et Al.University of Pittsburgh Medical Center, Pennsylvania, USAPacing Clin Electrophysiol. 2002 Aug;25(8):1172-8.

PRODUCT Chilli™ SUCCESS RATES 98% NUMBER of PATIENTS 28



“Randomized comparison of efficacy of cooled tip catheter ablation of atrial flutter: anatomic versus electrophysiological complete isthmus block.”Madrid AH, et Al.Cardiology Department, Ramon y Cajal Hospital, Madrid, Spain.Pacing Clin Electrophysiol. 2001 Oct;24(10):1525-33.

PRODUCT Chilli™ SUCCESS RATES 100% NUMBER of PATIENTS 8 pigs


http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&term=%22Madrid+AH%22%5BAuthor%5D


“Prospective randomized comparison of irrigated-tip versus conventional-tip catheters for ablation of common flutter.”Jais P et Al.Hopital Cardiologique du Haut-Leveque, Bordeaux-Pessac, France.Circulation. 2000 Feb 22;101(7):772-6.

PRODUCT Thermocool™ Biosense Webster SUCCESS RATES 100% NUMBER of PATIENTS 24


http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&term=%22Jais+P%22%5BAuthor%5D


“Pattern of isthmus conduction recovery using open cooled and solid large-tip catheters for radiofrequency ablation of typical atrial flutter.”Ventura R, University Hospital Hamburg-Eppendorf, Hamburg, Germany.

J Cardiovasc Electrophysiol. 2004 Oct;15(10):1131-2.



http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&term=%22Ventura+R%22%5BAuthor%5D


“Effect of isthmus anatomy and ablation catheter on radiofrequency catheter ablation of the cavotricuspid isthmus.”Da Costa A, et Al.University Hospital Jean Monnet, Saint-Etienne, France.

Circulation. 2004 Aug 31;110(9):1030-5.




“Use of different catheter ablation technologies for treatment of typical atrial flutter: acute results and long-term follow-up.”Marrouche NF, et Al.Cleveland Clinic Foundation,Cleveland,USA.

Pacing Clin Electrophysiol. 2003 Mar;26(3):743-6.

PRODUCT Chilli I I™ SUCCESS RATES 100% NUMBER of PATIENTS 39



“Prospective randomized comparison of closed cooled-tip versus 8-mm-tip catheters for radiofrequency ablation of typical atrial flutter.”Schreieck J, et Al.Deutsches Herzzentrum Munchen, Munich, Germany.

Cardiovasc Electrophysiol. 2002 Oct;13(10):980-5




“Primary closed cooled tip ablation of typical atrial flutter in comparison to conventional radiofrequency ablation.”Spitzer SG, et Al.Institute of Cardiovascular Research, Dresden, Germany.

Europace. 2002 Jul;4(3):265-71.




“Prospective randomised comparison of irrigated-tip and large-tip catheter ablation of cavotricuspid isthmus-dependent atrial flutter.”Scavee C, Jais P, Haissaguerre M, et Al.Hopital Cardiologique du Haut-Leveque, Bordeaux-Pessac, France.

Eur Heart J. 2004 Jun; 25(11): 963-9.




“Predictors of recurrence following catheter ablation of atrial fibrillation using an irrigated-tip ablation catheter.”Vasamreddy CR, et Al.Johns Hopkins University School of Medicine, Baltimore, USA.J Cardiovasc Electrophysiol. 2004 Jun;15(6):692-7.



http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&term=%22Vasamreddy+CR%22%5BAuthor%5D


“Saline-cooled versus standard radiofrequency catheter ablation for infarct-related ventricular tachycardias.”Soejima K, et Al.Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.Circulation. 2001 Apr 10;103(14):1858-62.

PRODUCT Chilli I I™ Thermocool™ Biosense Webster

SUCCESS RATES 90% NUMBER of PATIENTS 33


http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&term=%22Soejima+K%22%5BAuthor%5D


“Catheter ablation of ventricular tachycardia in patients with structural heart disease using cooled radiofrequency energy: results of a prospective multicenter study.” Calkins H, et Al.Johns Hopkins University School of Medicine, Baltimore, USA.

J Am Coll Cardiol. 2000 Jun;35(7):1905-14.



http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&term=%22Calkins+H%22%5BAuthor%5D


Chilli II™ Cooled Ablation CatheterConclusion

Chilli IIPositioning

AFIB

ClinicalNeeds

•Minimize Coagulum•Minimize secondary complications•Linear Ablation•Tip Contact•Access Anatomy•Deep Lesion

Customer Evaluation

•1 x AFL + 1 x AFIB Cases•BSC Generator•STD & K2 backup•Order per List

Catheter Features

•Cooled 7f/4mm Tip•Closed loop cooling•Bi-wing Knob & mechanical steering•HT Distal and Proximal•Active Steering & proximal tubing•Cooled 7f/4mm

EP SALES TRAINING Chilli II™ Cooled Ablation Catheter.

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